OBJECTIVES: Cross specialty primary care of patients with prostate cancer is challenging as patients face difficult treatment decisions due to multiple equivalent treatment options, an individual mix ...of comorbidities, personal preferences and considerable psychological burden following a cancer diagnosis. Several decision aids exist, but these have primarily been targeted to physicians and their effects have not been studied by means of evidence based medicine. To mitigate, patients increasingly turn to internet-based research before and after consultations. To improve shared treatment decision making and patient's health literacy a comprehensive German online-program (Prostana) has been developed based on medical guidelines. The program's key element is a patient centric dialogue software which tailors information to the needs of the patient in a highly patient friendly language. The objective and primary endpoint of the EasiPR03 study is to evaluate patients' satisfaction with their treatment decision. METHODS: Prospective multicenter and cluster-randomized controlled trial with cross over-design.To avoid spillover effects, study centers are randomized into either control- or intervention group. In the intervention group patients are offered Prostana, in the control group patients are given a standardized evidence based leaflet. Patients with a first time diagnosis are included in the study. Based on the primary endpoint the sample size has been calculated to 464 patients. The evaluation will follow Intention-to-Treat principle and analyze, among other parameters, differences in satisfaction with treatment decision using the Satisfaction with Decision Scale (SWD). RESULTS: An application for an ethics vote has been submitted in April 2017. The EasiPR03 aims to start recruitment in September 2017. First interim results are expected by January 2018. CONCLUSIONS: Given the rapid advancements in digital healthcare, high quality outcomes research studies on digital interventions and patient satisfaction are lacking. The EasiPR03 study can provide insight how innovative online-based software supports patients, relatives and physicians.
Background Viral reactivation is a nearly universal occurrence for children undergoing hematopoietic stem cell transplantation. (HSCT). HSCT removes the BKV specific T-cells that control BKV, ...resulting in the reactivation of BKV. BKV reactivation puts HSCT recipients at an increased risk for serious transplant complications, including graft vs. host disease (GVHD), thrombotic microangiopathy (TMA), and most notably, hemorrhagic cystitis (HC). Previous research has shown that anti-BKV directed T-cells generated ex vivo can control BKV, but this therapy is not widely available. In addition, without animal models and without direct access to bladder tissue, understanding of mechanisms of cystitis is very limited. We hypothesize that shed urothelial cells derived from urine can be used as a source of material for the investigation of individual susceptibility to BKV cystitis and that differences in innate immunity in the urothelium regulate risk of cystitis in children undergoing HSCT.Methods Urine samples were collected prospectively from children receiving HSCT once weekly starting prior to HSCT through 100 days after stem cell infusion, aliquoted, and stored at -80 C. Prospective systematic sample collection irrespective of clinical status, allowed the unbiased collection of a bank of cases of cystitis together with controls with viruria and no cystitis and controls with neither high-level viruria nor cystitis that are immediately available for study. Morphological and gene expression studies of urine sediment were used to determine host differences in viral sensors and APOBECs that may influence the risk of cystitis by studying shed urothelium from clinical urine samples.Results The morphology supported our hypothesis that most cells that we see in the urinary sediment are of urothelial origin and are suitable for study. APOBEC3B was significantly higher in those with BK viruria levels above the median as compared to those with BK viruria below the median, a Ct value of 16.6 versus 36.6 (p=0.028). In patients with viruria we saw increased expression of CXCL10 in those with viruria greater than the median (Ct median 15.3) compared with those with viruria less than median (median Ct value of 36, the cutoff for absent expression), (p=0.008). Similarly, with expression of IFNb, we saw a median Ct value of 16.8 in those with BK viruria less than the median and 14 in those with viruria greater than the median (p= 0.06).Conclusion We have identified urine sediment to be an appropriate source of cells to study for inflammation of the bladder. Our data indicate an important role for APOBEC3A in regulation of cystitis. This is an important observation because APOBEC3A is inducible, suggesting that we could develop a medication that would induce expression of APOBECS to protect against future cystitis
Objectives The use of selective antegrade cerebral perfusion (ACP) makes deep hypothermia nonessential for aortic arch replacement. Consequently, a growing tendency to increase the body temperature ...during circulatory arrest with ACP has recently been reported from various institutions. However, very little is known about the clinical effect of different modes of ACP (unilateral vs bilateral) on neurologic morbidity. Also, the safe limits of this approach for spinal chord and visceral organ protection are yet to be defined. Methods Between January 2000 and January 2011, 1002 consecutive patients underwent aortic arch repair during ACP (unilateral, 673; bilateral, 329) with mild systemic hypothermia (30°C ± 2°C; range, 26°-34°C) at 2 centers in Germany. The mean patient age was 62 ± 14 years, 663 patients (66%) were men, and 347 patients (35%) had acute type A dissection. Hemiarch replacement was performed in 684 patients (68%), and 318 (32%) underwent total arch replacement. Results The cardiopulmonary bypass time accounted for 158 ± 56 minutes and the myocardial ischemic time, 101 ± 41 minutes. Isolated ACP was performed for 36 ± 19 minutes (range, 9-135). We observed new postoperative permanent neurologic deficits in 28 patients (3%; stroke in 25 and paraplegia in 3) and transient neurologic deficits in 42 patients (4%). All 3 cases of paraplegia occurred in patients with acute type A dissection and a broad range of ACP times (24, 41, and 127 minutes). A trend was seen toward a reduced permanent neurologic deficit rate after unilateral ACP ( P = .06), but no difference was seen in the occurrence of transient neurologic deficits ( P = .6). Overall, the early mortality rate was 5% (n = 52). Temporary dialysis was necessary primarily after surgery in 38 patients (4%). When corrected for the unequal distribution of type A dissection, neurologic morbidity, early mortality, and the need for temporary dialysis were independent of the duration of ACP and were not affected by unilateral versus bilateral ACP. Conclusions Current data suggest that ACP and mild systemic hypothermic circulatory arrest can be safely applied to complex aortic arch surgery even in a subgroup of patients with up to 90 minutes of ACP. Unilateral ACP offers at least equal brain and visceral organ protection as bilateral ACP and might be advantageous in that it reduces the incidence of embolism arising from surgical manipulation on the arch vessels.
A unified linear theory that includes forced reconnection as a particular case of Alfvén resonance is presented. We consider a generalized Taylor problem in which a sheared magnetic field is subject ...to a time-dependent boundary perturbation oscillating at frequency \(\omega_0\). By analyzing the asymptotic time response of the system, the theory demonstrates that the Alfvén resonance is due to the residues at the resonant poles, in the complex frequency plane, introduced by the boundary perturbation. Alfvén resonance transitions towards forced reconnection, described by the constant-psi regime for (normalized) times \(t\gg S^{1/3}\), when the forcing frequency of the boundary perturbation is \(\omega_0\ll S^{-1/3}\), allowing the coupling of the Alfvén resonances across the neutral line with the reconnecting mode, as originally suggested in 1. Additionally, it is shown that even if forced reconnection develops for finite, albeit small, frequencies, the reconnection rate and reconnected flux are strongly reduced for frequencies \(\omega_0\gg S^{-3/5}\).
A unified linear theory that includes forced reconnection as a particular case of Alfvén resonance is presented. We consider a generalized Taylor problem in which a sheared magnetic field is subject ...to a time-dependent boundary perturbation oscillating at frequency ω0. By analyzing the asymptotic time response of the system, the theory demonstrates that the Alfvén resonance is due to the residues at the resonant poles, in the complex frequency plane, introduced by the boundary perturbation. Alfvén resonance transitions towards forced reconnection, described by the constant-psi regime for (normalized) times t≫S1/3, when the forcing frequency of the boundary perturbation is ω0≪S−1/3, allowing the coupling of the Alfvén resonances across the neutral line with the reconnecting mode, as originally suggested in Uberoi and Zweibel, (1999). Additionally, it is shown that even if forced reconnection develops for finite, albeit small, frequencies, the reconnection rate and reconnected flux are strongly reduced for frequencies ω0≫S−3/5.
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